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Completed

NCT Number: NCT01666223

Effect of Bile Acids on GLP-1 Secretion

The purpose of this study is to describe the physiological, pathophysiological and potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1) secretion in human glucose homeostasis.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen

Hellerup, Copenhagen, Denmark

About this study

The investigators hypothesize that even modest increments in endogenous GLP-1 secretion will elicit important antidiabetic effects of GLP-1. To evaluate whether bile acids have such effects, the investigators plan to perform intraduodenal infusion of two different bile acids and placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patients with type 2 diabetes

Inclusion criteria

  • danish caucasian ethnicity
  • normal haemoglobin
  • BMI > 25 kg/m2
  • HbA1c < 9%
  • informed consent

Exclusion criteria

  • liver disease(ALT and AST > upper reference limit)
  • gastrointestinal disease
  • liver and biliary tract disease
  • nephropathy (serum creatinine > 150 μM, and/or albuminuria)
  • treatment with insulin, glp-1 analogues and/ or DPP-4 inhibitors
  • treatment with medicine that can not be paused for 12 hours
  • previous abdominal surgery eg. cholecystectomy
  • BMI < 18,5 kg/m2 or > 35 kg/m2

Healthy Volunteers

Inclusion criteria

  • danish caucasian ethnicity
  • normal haemoglobin
  • HbA1c < 6,0 (American Diabetes Association guidelines)
  • informed consent

Exclusion criteria

  • liver disease(ALT and AST > upper reference limit)
  • gastrointestinal disease
  • liver and biliary tract disease
  • nephropathy (serum creatinine > 150 μM, and/or albuminuria)
  • treatment with medicine that can not be paused for 12 hours
  • previous abdominal surgery eg. cholecystectomy
  • BMI < 18,5 kg/m2 or > 35 kg/m2
  • first degree relatives diagnosed with diabetes
  • previously diagnosed with diabetes, or treated with antidiabetic agents

Treatment and study plan

Colesevelam

Drug

Colesevelam 3750 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.

Chenodeoxycholic Acid

Drug

1.250 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.

Saline

Other

100 ml saline

Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg

Drug

Colesevelam and chenodeoxycholic acid dissolved in 100 ml saline, administered in a duodenal tube at time = 0.

Primary outcomes

  1. Change in GLP-1

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

Secondary outcomes

  1. Change in insulin

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  2. Change in C-peptide

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  3. Change in glucagon

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  4. Change in glucagon-like-peptide 2 (GLP-2)

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  5. Change in glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  6. Change in peptide YY (PYY)

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  7. Change in oxyntomodulin

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  8. Change in bile acids

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  9. Change in gastrin

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  10. Change in CCK

    Time frame: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

  11. Change in appetite, satiety and prospective food consumption

    Time frame: At baseline, and 30, 60, 90, 120 and 180 minutes

    Evaluated by Visual Analog Scale (VAS)

  12. Change in gallbladder volume

    Time frame: -30, 0 (baseline), 30, 60, 120 og 180 minutes

    Evaluated by ultrasound

  13. Change in basal metabolic rate

    Time frame: At -30, 60 og 150 minutes

    Evaluated by indirect calorimetry

  14. Change in bile acid composition

    Time frame: At -30, 0, 30, 60, 120 og 180 minutes

    Evaluated by duodenal aspiration

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Effect of Bile Acids in the Gut on GLP-1 Secretion in Healthy Subjects and Patients With Type 2 Diabetes

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2012
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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